Label: TRUIST SUNSCREEN MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 3%

    Homosalate 8%

    Octisalate 5%

    Octocrylene 2.7%

    Oxybenzone 3%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
    • Sun Protection Measures.
      Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m. – 2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients

    Water (Aqua), C12-15 Alkyl Benzoate, Isononyl Isononanoate, Glycerin, Tropaeolum Majus Extract, Coffea Arabica (Coffee) Seed Extract, Zanthoxylum Alatum Fruit Extract, Tamarindus Indica Seed Polysaccharide, Dipotassium Glycyrrhizate, Glutamylamidoethyl Imidazole, Madecassoside, Asiaticoside, Silica, Sodium Hyaluronate Crosspolymer, Tribehenin PEG-20 Esters, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Carbomer, Cetearyl Alcohol, Trisodium Ethylenediamine Disuccinate, Aminomethyl Propanol, Caprylyl Glycol, Pentylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.

  • Questions or comments?

    1-855-878-4782

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Kimberly-Clark Global Sales, LLC
    2100 Winchester Road, Dept. SG
    Neenah, WI 54956

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    truist™

    care

    sunscreen
    moisturizer
    Broad Spectrum SPF 30

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TRUIST SUNSCREEN MOISTURIZER 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Tropaeolum Majus (UNII: 9G6ZOS4L87)  
    Arabica Coffee Bean (UNII: 3SW678MX72)  
    ZANTHOXYLUM ARMATUM FRUIT (UNII: ER3FV125H7)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Asiaticoside (UNII: PKO39VY215)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Tribehenin PEG-20 Esters (UNII: 84K9EH29Y9)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-605-1144 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2013
    2NDC:55118-605-77118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/20/2013
    Labeler - Kimberly-Clark (830997032)
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